Policy & Regulation News

HHS Releases New Actions to Expand COVID-19 Testing Across the US

The proposed actions will boost the availability of COVID-19 testing, increase domestic manufacturing of tests and testing supplies, and prepare the nation for the threat of variants.

COVID-19 Testing

Source: HHS Official

By Samantha McGrail

- HHS recently announced new actions to expand COVID-19 testing capacity across the US as part of President Joe Biden’s National Strategy for the COVID-19 Response and Pandemic Preparedness.

The proposed actions will boost the availability of tests for schools and underserved populations, increase domestic manufacturing of tests and testing supplies, and prepare the nation for the threat of variants by significantly increasing virus genome sequencing, HHS said. 

"The Department of Health and Human Services is committed to ensuring that we expand COVID-19 testing capabilities and invest in a diverse array of testing technology, capacity, and human resources to identify and contain the spread of the virus,” HHS Acting Secretary Norris Cochran said in the announcement.

“As part of the President’s national strategy to combat COVID-19, we will deploy every available resource to ensure that more individuals and families have access to testing options during this unprecedented time and that our nation is prepared to contain and prevent the spread of possible variants," Cochran continued. 

First, the administration will partner with the Department of Defense (DoD) to make a $650 million investment to expand testing opportunities for schools and underserved congregate settings, including homeless shelters.

HHS and DoD will also establish regional coordinating centers to organize increased COVID-19 testing capacity. Additionally, they will partner with laboratories across the US to collect specimens, perform COVID-19 tests, and report results to relevant public health agencies. 

The organizations plan to perform nearly 25 million COVID-19 tests per month. 

The initiative to expand COVID-19 testing capacity will especially help teachers, school staff, and students, which is an important step to support Biden’s plan to reopen schools for in-person learning, HHS said. 

Next, the Administration and DoD will make an $815 million investment to increase domestic manufacturing of testing supplies and raw materials to address testing shortages.

The testing materials include filter pipette tips, nitrocellulose used in antigen point-of-care tests, and specific injected molded plastics to house testing reagents. The investment will help to create additional domestic sources and expand existing facilities to boost test production. 

Lastly, HHS will tap the CDC to ramp up genomic sequencing of COVID-19 to better prepare for the threat of variants and slow the spread of disease. This initiative builds on an executive order signed by Biden in January to combat COVID-19 and prepare for future biological and pandemic threats. 

Throughout the pandemic, HHS has worked to increase COVID-19 vaccine development, COVID-19 testing, and overall support across the US.

For example, at the end of November, HHS issued guidance authorizing qualified pharmacy technicians and state-authorized pharmacy interns to administer COVID-19 vaccines and tests.

Pharmacy interns can also administer FDA-authorized vaccines that have been recommended by the Advisory Committee on Immunization Practices (ACIP) to individuals aged between three and 18 years old. This advisory does not pertain to the COVID-19 vaccine because the COVID-19 vaccine has not been approved for children that young.

But HHS noted requirements for administering the vaccine, including that the vaccination must be ordered by the supervising qualified pharmacists, the vaccine must be FDA-authorized or FDA-licensed, and the vaccine must be ordered and administered according to ACIP’s coronavirus vaccine requirements. 

Then at the end of January, the agency, newly under the Biden Administration, announced three ways the federal government will continue to support COVID-19 testing efforts by states and authorities into 2021. 

HHS said it will first provide weekly shipments of COVID-19 sample collection supplies to states and territories through May 2021, including swabs and transport media.

Next, the agency said it will collaborate with the General Services Administration (GSA) to provide streamlined processes for states, territories, and other government agencies to purchase point-of-care diagnostic tests.

And lastly, HHS said it will allocate an additional 30 million of Abbott’s BinaxNOW rapid antigen tests to support testing among high-risk populations. Abbott’s BinaxNOW test received FDA emergency use authorization at the beginning of September for use in point-of-care settings.